✦ Cancer Clinical Trials

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Melanoma

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Sep 14 – Sep 21, 2026

Efficacy and Safety of Co-Ablation Combined With Aintilimab for Metastatic Melanoma to the Liver (CryoCheck-001): A Phase II Trial.
▼MEDCOMM · Q1 JOURNAL - RANK #14/195TOP-TIER
This prospective single-arm phase II trial evaluated co-ablation combined with sintilimab (anti-PD-1) in 16 patients with liver-metastatic melanoma, administering sintilimab 200 mg every 3 weeks for up to eight cycles alongside co-ablation. The primary endpoint was 6-month progression-free survival (PFS) rate, with secondary endpoints including overall survival (OS), PFS time, and overall response rate (ORR). Three patients achieved partial response (ORR 18.75%), the 6-month PFS rate was 31.25% (95% CI: 15.1-64.6), median PFS was 3.94 months, and median OS was 16.67 months with 12- and 24-month OS rates of 53.8% and 28.7%, respectively. Grade ≥3 treatment-related adverse events occurred in 87.5% of patients, most commonly elevated liver enzymes, leading the authors to conclude the combination has a manageable safety profile and encouraging antitumor activity.
10.1002/mco2.70997

Aug 24 – Aug 31, 2026

B-cell depletion improves therapeutic index of combination checkpoint blockade in patients with advanced melanoma.
▼J CLIN INVEST · Q1 JOURNAL - RANK #5/195TOP-TIER
This prospective randomized clinical trial evaluated whether adding one cycle of rituximab to standard ipilimumab plus nivolumab could reduce immune-related adverse events (irAEs) in 14 patients with advanced melanoma. Patients were randomly assigned to receive either ipi/nivo alone (Arm-A, n=7) or ipi/nivo plus rituximab (Arm-B, n=7). The combination reduced grade≥3 irAEs (14% vs 57%) and improved 2-year G3-irAE-free survival (86% vs 29%, p=0.01) without compromising tumor response or survival; however, grade 3 hypersensitivity reactions to rituximab (43% in Arm-B) led to early trial closure. The authors concluded that B-cell depletion may favorably modulate checkpoint blockade immune activation and reduce irAE risk, but the trial was terminated early due to toxicity.
10.1172/JCI205606

Aug 17 – Aug 24, 2026

Immune-cytokine signature predicts survival in patients with advanced melanoma treated with oncolytic adenovirus TILT-123 and chemotherapy and IL-2-free adoptive TIL therapy.
▼J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This study is a correlative immunological analysis of the phase I TUNINTIL trial, a first-in-human, open-label, dose-escalation, multicenter trial evaluating the oncolytic adenovirus TILT-123 combined with adoptive tumor-infiltrating lymphocyte (TIL) therapy in 17 patients with checkpoint-inhibitor-resistant metastatic melanoma. The methodology involved systemic and intratumoral immune profiling (serum proteomics, flow cytometry, ELISpot, multiplex immunofluorescence, qPCR) with survival follow-up updated to March 2026, and outcomes were assessed via RECIST V.1.1 and PET-based criteria. Key findings included early innate immune activation with NK-cell expansion, increased intratumoral T-cell infiltration, and association of CD27+CD28+ memory-precursor CD8+ T cells with favorable outcomes, while elevated monocytic myeloid-derived suppressor cells and angiogenic/inflammatory cytokines correlated with disease progression; serum epidermal growth factor was identified as a candidate biomarker. The authors conclude that TILT-123 combined with TIL therapy is feasible without lymphodepleting chemotherapy or IL-2, and propose biomarker-guided future studies.
10.1136/jitc-2026-016003

T cell receptor repertoire dynamics and newly identified functional regulators of autologous tumor-infiltrating lymphocyte therapy in advanced solid tumors.
▼J TRANSL MED · Q1 JOURNAL - RANK #24/195
This phase I investigator-initiated trial evaluated the safety, feasibility, and preliminary efficacy of autologous tumor-infiltrating lymphocyte (TIL) therapy in twelve Asian patients with advanced melanoma, cervical, lung, or head and neck cancers who had progressed after standard therapies. Patients received lymphodepletion chemotherapy, TIL infusion, and high-dose IL-2, with tumor assessments per RECIST 1.1. The objective response rate was 33.3% (4/12), including one complete response and three partial responses, with a disease control rate of 75% (9/12). TCR sequencing showed dynamic clonal remodeling in responders, and CRISPR-mediated knockout of ASS1 or CEP20 enhanced TIL antitumor function, suggesting these genes as potential targets to improve TIL therapy.
10.1186/s12967-026-08781-z